Malignant Melanoma of SkinPhase 3NCT07890415
Using an Artificial Intelligence (AI) Tool for Melanoma Diagnosis
A Phase 3 study testing Clinical decision support tool in people with Malignant Melanoma of Skin and Other and Unspecified Malignant Neoplasm of Skin, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial summary
The purpose of this study is to learn whether a computer-based support tool called DEXI (Dermoscopy EXplainable Intelligence) can help dermatologists decide whether a lesion may be melanoma, a serious type of skin cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma of Skin, Other and Unspecified Malignant Neoplasm of Skin, Melanoma in Situ
- What is being tested?
- Clinical decision support tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,000 participants
- Where
- 8 sitesUnited States
- Study dates
- 15 Oct 2026to 15 Oct 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older at the time of scheduling the office visit.
- Presenting for an in-person office visit with an investigative provider at a participating clinical site during the study period. Both referral visits and recurring skin checks are eligible.
- Visit must have a mapped ICD-10 code with at least one of the following:
- iii. C43 - Malignant melanoma of skin C44 - Other and unspecified malignant neoplasm of skin D03 - Melanoma in situ iv. D04 - Carcinoma in situ of skin v. D18.0 - Hemangioma vi. D22 - Melanocytic nevi vii. D23 - Other benign neoplasms of skin viii. D48.5 - Neoplasm of uncertain behavior of skin ix. D48.9 - - Neoplasm of uncertain behavior, unspecified x. D49.2 - Neoplasm of unspecified behavior of bone, soft tissue, and skin xi. I78.1 - Nevus, non-neoplastic xii. L57 - Skin changes due to chronic exposure to nonionizing radiation xiii. L73.8 - Other specified follicular disorders xiv. L81.4 - Other melanin hyperpigmentation xv. L82 - Seborrheic keratosis xvi. Q82.5 - Congenital non-neoplastic nevus xvii. Z12.83 - Encounter for screening for malignant neoplasm of skin xviii. Z80.8 - Family history of malignant neoplasm of other organs or systems xix. Z85.82 - Personal history of malignant neoplasm of skin xx. Z86.006 - Personal history of melanoma in-situ xxi. Z86.007 - Personal history of in-situ neoplasm of skin
- Dermatologist conducting the visit must have undergone training for the how to use and interpret the CDS.
Who cannot join
- Telehealth-only, home, inpatient, emergency department, or procedure-only encounters without an in-office visit.
- If any image data captured on the patient were known to have been used for training or validating DEXI.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Memorial Sloan Kettering at Basking Ridge (All protocol activities)
Basking Ridge, New Jersey, 07920
Veronica Rotemberg, MD, 646-608-2367
- Recruiting
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)
Commack, New York, 11725
Veronica Rotemberg, MD, 646-608-2367
- Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Veronica Rotemberg, MD, 646-608-2367
- Recruiting
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748
Veronica Rotemberg, MD, 646-608-2367
- Recruiting
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645
Veronica Rotemberg, MD, 646-608-2367
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065
Veronica Rotemberg, MD, 646-608-2367
- Not yet recruiting
Stanford University (Data Collection Only)
Stanford, California, 94305
Albert Chiou, MD, MBA, 650-723-6316
- Recruiting
Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
Uniondale, New York, 11553
Veronica Rotemberg, MD, 646-608-2367
About this study
Official title: Pragmatic Randomized Controlled Trial of Artificial Intelligence for Melanoma Diagnosis (PRACTA-MEL) (AI)
The purpose of this study is to learn whether a computer-based support tool called DEXI (Dermoscopy EXplainable Intelligence) can help dermatologists decide whether a lesion may be melanoma, a serious type of skin cancer. DEXI uses artificial intelligence, or AI, which means computer technology that looks for patterns in images and information. DEXI works within a software program called the DermaGraphix Visualizer, which displays and organizes skin and lesion images. The goal of this study is to see whether DEXI can help doctors find melanoma and reduce biopsies that may not be needed.
- Conditions
- Malignant Melanoma of Skin, Other and Unspecified Malignant Neoplasm of Skin, Melanoma in Situ, Carcinoma in Situ of Skin, Hemangioma, Melanocytic Nevi
- Being tested
- Clinical decision support tool
- Keywords
- Malignant melanoma of skin, Other and unspecified malignant neoplasm of skin, Melanoma in situ, Carcinoma in situ of skin, Hemangioma, Melanocytic nevi, Other benign neoplasms of skin, Neoplasm of uncertain behavior of skin, Neoplasm of uncertain behavior, unspecified, Neoplasm of unspecified behavior of bone, soft tissue, and skin, Nevus, non-neoplastic, Skin changes due to chronic exposure to nonionizing radiation, Other specified follicular disorders, Other melanin hyperpigmentation, Seborrheic keratosis, Congenital non-neoplastic nevus, Memorial Sloan Kettering Cancer Center, 26-209
- Medical subject headings
- Melanoma, Hemangioma, Nevus, Pigmented, Nevus, Keratosis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical decision support toolDiagnostic test
Also called CDS
Clinical decision support tool (CDS) featuring the DEXI (Dermoscopy EXplainble Intelligence) algorithm within the setting of outpatient dermatology visits at both a dedicated cancer center dermatology service (MSK) and general medical dermatology clinics within a large health network (SU), where melanoma screening or assessment occurs as part of standard care.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Visit | Experimental | Clinical decision support/CDS available to investigative providers; CDS may or may not be used at a given dermatology visit Receives: Diagnostic Test: Clinical decision support tool |
| Control Visit | No intervention | Clinical decision support/CDS unavailable (technically disabled); Standard of care/SOC skin examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall melanoma detection rate per visit
The primary objective is to evaluate the impact of a clinical decision support tool (CDS) on precision to diagnose melanoma within in-office dermatology visits. Melanoma detection efficiency will be measured (a) total biopsies to rule out melanoma per 100 visits and (b) melanoma diagnosed per 100 visits, compared between visits carried out under standard of care (SOC) versus visits in which the dermatologist (provider) has access to the CDS (enhanced visits).
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start15 Oct 2026
- Primary completion15 Oct 2029 (estimated)
- Study completion15 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Melanoma of SkinStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Canfield Scientific Inc.
- Responsible party
- Sponsor
- Investigators
- Veronica Rotemberg, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890415
- Sponsor's protocol ID
- 26-209
- Other IDs
- 1R01CA293974-01A1
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Randomized Controlled Trial of Artificial Intelligence for Melanoma Diagnosis (PRACTA-MEL) (AI)
- ClinicalTrials.gov ID
- NCT07890415
- Acronym / sponsor ID
- 26-209
- Conditions
- Malignant Melanoma of Skin, Other and Unspecified Malignant Neoplasm of Skin, Melanoma in Situ, Carcinoma in Situ of Skin, Hemangioma, Melanocytic Nevi
- Keywords
- Malignant melanoma of skin, Other and unspecified malignant neoplasm of skin, Melanoma in situ, Carcinoma in situ of skin, Hemangioma, Melanocytic nevi, Other benign neoplasms of skin, Neoplasm of uncertain behavior of skin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14,000 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Canfield Scientific Inc.
- Study start
- 15 Oct 2026 (actual)
- Primary completion
- 15 Oct 2029 (estimated)
- Study completion
- 15 Oct 2029 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn whether a computer-based support tool called DEXI (Dermoscopy EXplainable Intelligence) can help dermatologists decide whether a lesion may be melanoma, a serious type of skin cancer. DEXI uses artificial intelligence, or AI, which means computer technology that looks for patterns in images and information. DEXI works within a software program called the DermaGraphix Visualizer, which displays and organizes skin and lesion images. The goal of this study is to see whether DEXI can help doctors find melanoma and reduce biopsies that may not be needed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Visit | Experimental | Diagnostic Test: Clinical decision support toolClinical decision support/CDS available to investigative providers; CDS may or may not be used at a given dermatology visit |
| Control Visit | No intervention | –Clinical decision support/CDS unavailable (technically disabled); Standard of care/SOC skin examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older at the time of scheduling the office visit.
- Presenting for an in-person office visit with an investigative provider at a participating clinical site during the study period. Both referral visits and recurring skin checks are eligible.
- Visit must have a mapped ICD-10 code with at least one of the following:
- iii. C43 - Malignant melanoma of skin C44 - Other and unspecified malignant neoplasm of skin D03 - Melanoma in situ iv. D04 - Carcinoma in situ of skin v. D18.0 - Hemangioma vi. D22 - Melanocytic nevi vii. D23 - Other benign neoplasms of skin viii. D48.5 - Neoplasm of uncertain behavior of skin ix. D48.9 - - Neoplasm of uncertain behavior, unspecified x. D49.2 - Neoplasm of unspecified behavior of bone, soft tissue, and skin xi. I78.1 - Nevus, non-neoplastic xii. L57 - Skin changes due to chronic exposure to nonionizing radiation xiii. L73.8 - Other specified follicular disorders xiv. L81.4 - Other melanin hyperpigmentation xv. L82 - Seborrheic keratosis xvi. Q82.5 - Congenital non-neoplastic nevus xvii. Z12.83 - Encounter for screening for malignant neoplasm of skin xviii. Z80.8 - Family history of malignant neoplasm of other organs or systems xix. Z85.82 - Personal history of malignant neoplasm of skin xx. Z86.006 - Personal history of melanoma in-situ xxi. Z86.007 - Personal history of in-situ neoplasm of skin
- Dermatologist conducting the visit must have undergone training for the how to use and interpret the CDS.
Key exclusion criteria (2 listed)
- Telehealth-only, home, inpatient, emergency department, or procedure-only encounters without an in-office visit.
- If any image data captured on the patient were known to have been used for training or validating DEXI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical decision support toolAlso: CDSClinical decision support tool (CDS) featuring the DEXI (Dermoscopy EXplainble Intelligence) algorithm within the setting of outpatient dermatology visits at both a dedicated cancer center dermatology service (MSK) and general medical dermatology clinics within a large health network (SU), where melanoma screening or assessment occurs as part of standard care. | Diagnostic test | Investigational Visit |
Primary outcome
Overall melanoma detection rate per visit
Time frame: up to 4 years
The primary objective is to evaluate the impact of a clinical decision support tool (CDS) on precision to diagnose melanoma within in-office dermatology visits. Melanoma detection efficiency will be measured (a) total biopsies to rule out melanoma per 100 visits and (b) melanoma diagnosed per 100 visits, compared between visits carried out under standard of care (SOC) versus visits in which the dermatologist (provider) has access to the CDS (enhanced visits).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Veronica Rotemberg, MD principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clinical decision support tool in people with Malignant Melanoma of Skin and Other and Unspecified Malignant Neoplasm of Skin, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veronica Rotemberg, MD (646-608-2367, rotembev@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall melanoma detection rate per visit (time frame: up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.